BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3895101 · Received June 25, 2014

    Report

    Report Number
    2955842-2014-03903
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S PITCH CABLE WAS BROKEN. THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINED THE CRIMP IS STILL INSTALLED IN CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING: THE INSTRUMENT'S DISTAL PULLEY HAD MECHANICAL INDENTATION AND BURRS. THERE WAS AN INDENTATION AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. FAILURE ANALYSIS CONCLUDED THAT THE MECHANICAL INDENTATION AND BURRS DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI SURGICAL PROCEDURE, IT WAS NOTED THAT A FRAYED WIRE WAS OBSERVED ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371865 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-07 N10140501 085

    Patients

    Seq Age Sex Outcome Treatment
    1